# K240611: IVYLASER Diode laser hair removal system (IVY-HR-Alloy)

- Pathway: 510(k) (Traditional)
- Applicant: Ivylaser (Beijing) Technology Co.,Ltd
- Decided: Jun 20, 2024 after 107 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K943450 (1995). 566 ancestors in all.
No later device cites it as a predicate yet.
0 of 567 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222064: The Alma Soprano Titanium, Alma Lasers, Inc. (2022) Summary page 5.

## Cited in the summary but kept off the family tree
- K230580: Diode Laser System, Smedtrum Medical Technology Co., Ltd. (2023). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode(FHR).

Source page: https://510kreport.com/device/K240611
Methodology: https://510kreport.com/methodology